ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS

System, Simulation, Radiation Therapy

GE HUNGARY KFT

The following data is part of a premarket notification filed by Ge Hungary Kft with the FDA for Advantagesim Md With Ct Atlas-based Contouring And Re-planning Options.

Pre-market Notification Details

Device IDK132045
510k NumberK132045
Device Name:ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
ClassificationSystem, Simulation, Radiation Therapy
Applicant GE HUNGARY KFT 3000 N GRANDVIEW DIVISION: DBA GE HEALTHCARE Waukesha,  WI  53188
ContactStephen Slavens
CorrespondentStephen Slavens
GE HUNGARY KFT 3000 N GRANDVIEW DIVISION: DBA GE HEALTHCARE Waukesha,  WI  53188
Product CodeKPQ  
CFR Regulation Number892.5840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-02
Decision Date2013-09-04
Summary:summary

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